MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problem Defective Device (2588)

Patient Problems Coagulation Disorder (1779); Internal Organ Perforation (1987); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Cardiac Perforation (2513)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused 4 mm aortic and 3 mm mesenteric perforation.The indication for the filter implant has not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported event could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to 4 mm aortic and 3 mm mesenteric perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused 4 mm aortic and 3 mm mesenteric perforation.The patient reported becoming aware of perforation of filter struts outside the ivc, blood clots, clotting, and occlusion of the ivc approximately eight years and four months post implant.The patient also reported anxiety related to the filter.According to the implant record the indication for the filter implant was a history of lung cancer and was status post pulmonary thromboembolism secondary to a right lower extremity deep vein thrombosis (dvt).The patient required staging lymph node biopsy mediastinoscopy as well as potential resection of the lung mass with frequent interruptions of coumadin.The filter was placed via the right femoral vein and deployed above the bifurcation and below the renal veins.The patient tolerated the procedure well and without complication.The product remains implanted and unavailable for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots, clotting, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.).

Event Description

Per the implant records, the patient was reported to have a history of lung cancer and was status post pulmonary thromboembolism secondary to a right lower extremity deep vein thrombosis (dvt).The patient was treated with both coumadin and lovenox injections and required multiple procedures including a staging lymph node biopsy mediastinoscopy as well as potential resection of the lung mass.The inferior vena cava (ivc filter) was indicated due to frequent interruptions of coumadin, hypercoagulable state and history of pulmonary embolism (pe) and dvt.The patient was prepped and draped in the usual fashion.The left groin was infiltrated with xylocaine for local anesthesia.The right femoral vein was cannulated via the micro puncture technique and a sheath was placed.An ivc venogram/venacavogram was performed utilizing a pigtail catheter.The trapease ivc filter was then deployed above the bifurcation and below the renal veins.The patient tolerated the procedure well and without complication.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, blood clots, clotting, and occlusion of the ivc becoming aware of these events approximately eight years and four months after the filter implantation, and further experienced anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15452870
• MDR Text Key: 300224628
• Report Number: 9616099-2022-05997
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15602826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK 6-FRENCH PIGTAIL CATHETER; UNK 6-FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male